BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 3790874 · Received May 5, 2014

    Report

    Report Number
    3004209178-2014-08532
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Report Date
    April 14, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 97740, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 97754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING IMPLANT THE PATIENT HAD SYMPTOMS IN BOTH FEET. IT WAS FURTHER REPORTED THAT THE PATIENT HAD PAIN IN THEIR FOOT. THE PATIENT REPORTEDLY THOUGHT IT WAS BECAUSE THEY HAD SLEPT IN A RECLINER. IT WAS NOTED THAT THE PATIENT HAD ALWAYS SLEPT IN A RECLINER PRIOR TO IMPLANT. IT WAS ALSO REPORTED THAT THE FIRST TWO DAYS THE PATIENT FOUND A LITTLE PAIN IN THE ARCH IN BOTH FEET. THE PATIENT REPORTEDLY THOUGHT THAT THE LEFT SIDE MIGHT HAVE STARTED FIRST BECAUSE VIBRATION IS HEAVILY ON THE LEFT SIDE INSTEAD OF THE RIGHT SIDE. AT THE TIME OF THE REPORT BOTH OF THE PATIENT¿S FEET REPORTEDLY ACHED AND THE PATIENT COULD NOT TAKE LONG WALKS. THE PATIENT STATED THAT THEY HAD NO WAY OF TESTING IF THE SCIATIC PAIN WAS GONE. THE PATIENT REPORTEDLY ONLY HAD PAIN WHEN THEY WALKED AND THEY HAD NOT BEEN ABLE TO WALK TO SEE IF THE STIMULATOR WAS HELPING WITH THE SCIATIC PAIN. IT WAS NOTED THAT THE PATIENT HAD TURNED THE STIMULATION DOWN VERY LOW ON THE MORNING OF THE REPORT AND THEY DID NOT FEEL IT. IT WAS ALSO NOTED THAT WHEN THE PATIENT PUTS PRESSURE ON IT THEY DID NOT FEEL VIBRATIONS ANYMORE; THIS WAS REPORTEDLY DESCRIBING POSITIONAL MOVEMENT. THE PATIENT REPORTEDLY HAD PAIN IN THEIR FEET AND LEGS AND THOUGHT IT WOULD GO AWAY. IT WAS ALSO NOTED THAT THE PATIENT FIGURED IT WAS RELATED TO THE STIMULATOR AND TURNED IT DOWN. THE PATIENT HAD REPORTEDLY BEEN EXPERIENCING THIS FOR 2.5 DAYS PRIOR TO THE REPORT. IT WAS NOTED THAT THE PATIENT HAD RHEUMATOID ARTHRITIS WHEN THEY WERE YOUNG. THE PATIENT HAD ALSO REPORTEDLY GOTTEN IN A HOT TUB TO WARM UP THEIR FEET AND THEN USED A HEATER AND PUT SOCKS ON; THIS REPORTEDLY MADE IT STAY THE SAME AND DID NOT RELIEVE IT. THE PATIENT THOUGHT THAT MAYBE THEIR FEET WERE COLD BECAUSE THEY HAVE SENSITIVE FEET. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266408 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR